Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma
About the study
The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417 (sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of BGB-11417 monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria:
- Histologically confirmed diagnosis of MCL
- Prior systemic treatments for MCL (at least one line of anti-cluster of differentiation 20 (anti-CD20) based immune or chemoimmunotherapy and at least one kind of covalent or non-covalent adequate Bruton Tyrosine Kinase (BTK) inhibitor).
- Relapsed/refractory disease
- Presence of measurable disease
- Availability of archival tissue confirming diagnosis of MCL, or willing to undergo fresh tumor biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
- Adequate organ function
EXCLUSION CRITERIA
Key Exclusion Criteria:
- Known central nervous system involvement by lymphoma
- Prior malignancy other than MCL within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer.
- Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199).
- Prior autologous stem cell transplant within the last 3 months; or prior autologous chimeric antigen receptor T-cell therapy within the last 3 months; or prior allogeneic stem cell transplant within the last 6 months or currently has an active graft-vs-host disease requiring the use of immunosuppressants.
- Clinically significant cardiovascular disease.
- Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.
- Active fungal, bacterial or viral infection requiring systemic treatment.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Mantle Cell Lymphoma,Refractory Mantle Cell Lymphoma (MCL),Relapsed Mantle Cell Lymphoma
Age
18+
Phase
PHASE1/PHASE2
Participants Needed
126
Est. Completion Date
Aug 31, 2027
Treatment Type
INTERVENTIONAL
Sponsor
BeiGene
ClinicalTrials.gov NCT Identifier
NCT05471843
Study Number
BGB-11417-201
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